FDA approves new pain drugs

The US Food and Drug Administration has given the green light to two new pain drugs – Elan’s Prialt (ziconotide) and Pfizer’s Lyrica (pregabalin) – both of which are expected to be big earners for the companies concerned.

Specifically, Prialt has been given the nod to manage severe chronic pain in patients for whom intrathecal therapy – or injection into the spinal cord – is warranted, and who are intolerant of, or refractory to, other treatments. Prialt is the first in a new class of drugs known as N-type calcium channel blockers and was originally filed in the USA in 2000 and given a six-month priority review. However, in June that same year, the FDA gave it only a partial nod, requesting an additional trial be conducted looking at the safety and efficacy of lower doses of Prialt, plus a slower titration schedule. Elan added new data into its US regulatory dossier last summer [[29/06/04e]], and now hopes that Prialt will be available in the USA late this month. The drug recently won backing from the European advisory body, with a final decision on approvability expected within the next couple of months [[19/11/04c]].

Lyrica, which is forecast to help offset sales of Pfizer’s top-selling epilepsy drug, Neurontin (gabapentin), after it became the victim of generic competition [[16/12/04e]], [[14/10/04d]], has been approved to manage neuropathic pain associated with diabetic peripheral neuropathy and post-herpetic neuralgia. Although the company notes that this is the first product approved in both these indications, some analysts were disappointed that the FDA ruled that the drug should be classed as a controlled substance, which could hamper sales. Nevertheless, the world’s largest pharmaceutical company says that Lyrica will be available “in the near future.”